MAUDE Adverse Event Report: SYNTHES SELZACH VERTECEM V+ SYRINGE KIT; CEMENT DISPENSER

Catalog Number 03.702.215S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Other udi: (b)(4).Implant and explant dates: device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Initial reporters phone number: (b)(6).Device history records review was conducted.The report indicates that the: 03.702.215s / 6072679 manufacturing location: (b)(4).Supplier: symatese device manufacturing date: 28 oct 2016, expiry date: 01 oct 2021.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that during surgery while filling the cement into the white 2cc syringes, the stamps of the syringes backed out of the outer tube, the stop was not working.All syringes had the same problem.There was no patient harm and the outcome was fine.The surgery was not prolonged and was successfully completed.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Remove event date, date of the event is unknown.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VERTECEM V+ SYRINGE KIT
• Type of Device: CEMENT DISPENSER
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6595414
• MDR Text Key: 76154910
• Report Number: 3000270450-2017-10183
• Device Sequence Number: 1
• Product Code: OAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 03.702.215S
• Device Lot Number: 6072679
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1